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Intensive BP Control in Patients With Type 2 Diabetes
TAKE-HOME MESSAGE
- The study assessed the effectiveness of intensive treatment targeting a systolic blood pressure (BP) of less than 120 mm Hg versus standard treatment targeting a systolic BP of less than 140 mm Hg in reducing the risk of major cardiovascular disease events in patients with type 2 diabetes. Intensive BP treatment was associated with a lower incidence of major cardiovascular events than standard treatment; however, the prevalence of adverse effects, such as hypotension and hyperkalemia, was higher in the intensive treatment group.
- These findings suggest that intensive treatment targeting a systolic BP of less than 120 mm Hg may help reduce cardiovascular complications in patients with type 2 diabetes.
abstract
This abstract is available on the publisher's site.
Access this abstract nowBACKGROUND
Effective targets for systolic blood-pressure control in patients with type 2 diabetes are unclear.
METHODS
We enrolled patients 50 years of age or older with type 2 diabetes, elevated systolic blood pressure, and an increased risk of cardiovascular disease at 145 clinical sites across China. Patients were randomly assigned to receive intensive treatment that targeted a systolic blood pressure of less than 120 mm Hg or standard treatment that targeted a systolic blood pressure of less than 140 mm Hg for up to 5 years. The primary outcome was a composite of nonfatal stroke, nonfatal myocardial infarction, treatment or hospitalization for heart failure, or death from cardiovascular causes. Multiple imputation was used for missing outcome data, with an assumption that the data were missing at random.
RESULTS
Of 12,821 patients (6414 patients in the intensive-treatment group and 6407 in the standard-treatment group) enrolled from February 2019 through December 2021, 5803 (45.3%) were women; the mean (±SD) age of the patients was 63.8±7.5 years. At 1 year of follow-up, the mean systolic blood pressure was 121.6 mm Hg (median, 118.3 mm Hg) in the intensive-treatment group and 133.2 mm Hg (median, 135.0 mm Hg) in the standard-treatment group. During a median follow-up of 4.2 years, primary-outcome events occurred in 393 patients (1.65 events per 100 person-years) in the intensive-treatment group and 492 patients (2.09 events per 100 person-years) in the standard-treatment group (hazard ratio, 0.79; 95% confidence interval, 0.69 to 0.90; P<0.001). The incidence of serious adverse events was similar in the treatment groups. However, symptomatic hypotension and hyperkalemia occurred more frequently in the intensive-treatment group than in the standard-treatment group.
CONCLUSIONS
Among patients with type 2 diabetes, the incidence of major cardiovascular events was significantly lower with intensive treatment targeting a systolic blood pressure of less than 120 mm Hg than with standard treatment targeting a systolic blood pressure of less than 140 mm Hg. (Funded by the National Key Research and Development Program of the Ministry of Science and Technology of China and others; BPROAD ClinicalTrials.gov number, NCT03808311.).
Additional Info
Disclosure statements are available on the authors' profiles:
Intensive Blood-Pressure Control in Patients with Type 2 Diabetes
N. Engl. J. Med 2024 Nov 16;[EPub Ahead of Print], Y Bi, M Li, Y Liu, T Li, J Lu, P Duan, F Xu, Q Dong, A Wang, T Wang, R Zheng, Y Chen, M Xu, X Wang, X Zhang, Y Niu, Z Kang, C Lu, J Wang, X Qiu, A Wang, S Wu, J Niu, J Wang, Z Zhao, H Pan, X Yang, X Niu, S Pang, X Zhang, Y Dai, Q Wan, S Chen, Q Zheng, S Dai, J Deng, L Liu, G Wang, H Zhu, W Tang, H Liu, Z Guo, G Ning, J He, Y Xu, W WangFrom MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.
After the ACCORD blood pressure (BP) trial reported in 2010 that an intensive systolic BP goal of less than 120 mm Hg versus less than 140 mm Hg in more than 7000 participants with hypertension and type 2 diabetes did not significantly reduce the risk of cardiovascular (CV) events,1 there was uncertainty regarding whether intensive BP goals were appropriate in that population. However, in 2015, SPRINT reported that the same intensive systolic BP goal (<120 mm Hg) reduced the risk of CV events and mortality by 25% to 30% compared with a standard systolic BP goal (<140 mm Hg) in a broad high-risk population with hypertension (N > 9000); however, patients with diabetes were excluded from that trial.2
Although the incidence of stroke was significantly reduced in the ACCORD BP trial, the reduction in the incidence of CV events was comparable in degree (approximately 26%) in the standard glycemia goal subgroups across both the ACCORD BP trial and SPRINT.3 Furthermore, individuals with prediabetes in SPRINT benefited, whereas subgroups with diabetes in more recent intensive systolic BP goal studies from China (STEP,4 ESPRIT5) showed similar CV benefits without heterogeneity. However, none of these studies showed an independent significant reduction in the incidence of CV events among patients with both hypertension and diabetes.
Now there is strong evidence from another trial conducted in China, the Blood Pressure Control Target in Diabetes (BPROAD) trial, that an intensive systolic BP goal (<120 mm Hg) reduces the incidence of CV events in patients with hypertension and diabetes. The results were presented at the American Heart Association meeting in November 2024 and simultaneously published online in The New England Journal of Medicine. In the BPROAD trial, 12,821 participants aged 50 years or older with type 2 diabetes, elevated systolic BP, and an increased risk of CV disease were randomized to receive either intensive treatment (systolic BP goal <120 mm Hg) or standard treatment (systolic BP goal <140 mm Hg) at 145 clinical sites across China.
Like in SPRINT, the median systolic BP after 1 year was 118 mm Hg in the intensive treatment group. During a median follow-up period of 4.2 years, the primary composite CV outcome — comprising stroke, MI, HF, or CV death — was reduced by 21% (P < .001) with intensive BP treatment compared with standard BP treatment. The CV benefits were comparable across all prespecified subgroups. Overall, the incidence of serious adverse events was comparable between the randomized groups. Considering the previous suggestive evidence, the BPROAD trial now provides definitive evidence that intensive treatment for achieving a systolic BP goal of less than 120 mm Hg reduces the incidence of CV events.
References
Recent years have seen numerous randomized clinical trials evaluating intensive systolic blood pressure (BP) targets (≤120 mm Hg) versus the traditional target of 140 mm Hg. While the SPRINT trial in 2015 was pivotal, more recent trials like STEP and ESPRIT have reinforced the cardiovascular (CVD) benefits of intensive BP targets. However, the first landmark trial in this field was ACCORD, which exclusively enrolled patients with diabetes.
Unlike SPRINT, STEP, and ESPRIT, the ACCORD trial was technically a null trial, showing no significant benefit for the primary composite outcome. This has led to some speculation that patients with diabetes may be an exception to the rule and may not benefit from intensive BP treatment. However, ACCORD was also approximately half the size of other similar intensive treat-to-target trials and was underpowered. Later trials learned the lesson of this mistake. Importantly, ACCORD demonstrated a significant reduction in stroke and numerical reductions in other primary outcome components. Furthermore, extended follow-up of ACCORD (resulting in more events and better power) demonstrated a statistically significant reduction in the primary outcome, as did a post hoc analysis involving 50% of ACCORD participants randomized in a factorial fashion to the standard glycemia arm (targeting an HbA1c of ≤7% as is currently targeted in clinical practice).
Therefore, guidelines, including the recent 2024 ESC guidelines on the management of elevated BP and hypertension, which I co-chaired, have typically recommended that patients with diabetes be targeted to the same intensive BP targets as other adults at high CVD risk. Nonetheless, there has been residual uncertainty about this topic.
Therefore, the results of BPROAD trial are very welcome and important. In this trial with a large sample size (N = 12,821) and exclusively enrolling adults with diabetes, randomization to a systolic BP target of less than 120 mm Hg reduced the risk of the primary composite endpoint of nonfatal stroke, nonfatal myocardial infarction, treatment or hospitalization for heart failure, and death from cardiovascular causes by 21% (P < .001).
I believe this uncertainty has now been eliminated, and we should treat patients with diabetes and a high BP the same way we treat others at risk for CVD.